Last updated: 01/27/2020 10:10:03

Meta-analysis of risk of intussusception after the first and the second dose of Rotarix and Rotateq

GSK study ID
201889
See study documents
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Meta-analysis of risk of intussusception after the first and the second dose of Rotarix and Rotateq
Trial description: The aim of this planned analyses linked to Post-Authorization Safety Study (PASS) is to assess the risk of Intussusception after the 1st and the 2nd dose of Rotarix and Rotateq vaccines and provide an overall estimate of the risk after each dose by combining results from different studies using meta-analysis method.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Relative risk of Intussusception (IS) following the 1st and the 2nd dose of Rotarix and Rotateq vaccines

Timeframe: During the 7 days (Day 0 - Day 6) after vaccination

Secondary outcomes:
Not applicable
Interventions:
  • Other: Data collection
    • Enrollment:
    1
    Primary completion date:
    2013-19-06
    Observational study model:
    Other
    Time perspective:
    Retrospective
    Clinical publications:
    Not applicable
    Medical condition
    Infections, Rotavirus
    Product
    SB444563
    Collaborators
    Not applicable
    Study date(s)
    June 2013 to June 2013
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Female & Male
    Age
    6 Weeks - 1 Year
    Accepts healthy volunteers
    none
    • Subjects (> 6 weeks of age) vaccinated with Rotarix and Rotateq vaccines who participated in studies that met the following criteria:
    • Post-marketing studies (no clinical trials);
    • Not Applicable
    Inclusion and exclusion criteria
    Inclusion criteria:

      Subjects (> 6 weeks of age) vaccinated with Rotarix and Rotateq vaccines who participated in studies that met the following criteria:

    • Post-marketing studies (no clinical trials);
    • Risk estimated for the 7-day period after vaccination;
    • Risk estimated for dose 1 and dose 2, separately;
    • Data obtained through active and/or passive surveillance on “confirmed” IS cases (Brighton or other method of case adjudication);
    • Full report or publication available.
    Exclusion criteria:

      Not Applicable

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

    Scientific result summary
    Available language(s): English
    Download document(s)
    Protocol and statistical analysis plan
    Available language(s): English
    Download document(s)
    Clinical study report
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Refer to study documents

    Recruitment status
    Study complete
    Actual primary completion date
    2013-19-06
    Actual study completion date
    2013-19-06

    Plain language summaries

    Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.

    Additional information about the trial

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